Summary

The treatment of the patients with recurrent and metastatic breast cancer remains a major
problem. There is still a lack of effective targeted therapy for Her-2 negative breast
cancer.Based on the present researches on the anti-angiogenesis drugs in advanced breast
cancer, the investigators believe that it is necessary to further explore the efficacy and
safety of apatinib in advanced breast cancer.

Eligibility Criteria

Female participants at least 18 years old.

Inclusion Criteria:
1. HER-2 negative advanced breast cancer with chest wall metastasis confirmed by
histology or cytological examination (patients who have received anthracyclines
and/or paclitaxel in adjuvant chemotherapy).
2. Patients with recurrence or metastasis who have received no more than two lines of
chemotherapy.
3. If hormone receptor is positive, endocrine therapy must have been performed for the
patients with recurrence or metastasis, or the recurrence or metastasis occurred in
less than two years of endocrine therapy.
4. ≥ 18 years old.
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
6. A life expectancy of more than 3 months.
7. At least one measurable site of disease confirmed by CT or MRI according to Response
Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria was required.
8. If the target lesions are lymph nodes, the short diameter is required to be less than
1.5cm and the target lesions are not suitable for surgical treatment; target lesions
have not been in radiotherapy or recurred in the radiation field.
9. Baseline blood routine examination in accordance with the following criteria:
neutrophil counts more than 1.5*109/L; platelet counts greater than 100*109/L;
hemoglobin greater than 9 g/dL (blood transfusion is allowed to achieve or maintain
the index)
10. Liver function in accordance with the following criteria: total bilirubin less than
1.5 times the upper limit of normal value; aspartate aminotransferase (AST), alanine
aminotransferase (ALT) less than 2.5 times the upper limit of normal value, less than
5 times the upper limit of normal value in patients with liver metastases.
11. Renal function in accordance with the following criteria: serum creatinine less than
1.25 times the upper limit of normal value, or the creatinine clearance rate
calculated greater than 50 mL/min;
12. Women with fertility are willing to take contraceptive measures in the trial: when
seven days before the drug delivery of serum or urine pregnancy test negative.
Exclusion Criteria:
1. receiving radiation therapy 28 days before enrolled. Radiotherapy before enrollment
to relieve the metastatic bone pain is allowed, but medullary bone radiated should
not exceed 30% of the total amount;
2. symptomatic central nervous system metastases;
3. current or recent (30 days before enrollment) use of another study drug or being
involved in another clinical study;
4. Other malignant tumors that have occurred within 5 years (except for the cured or
well-controlled cervical carcinoma in situ, skin squamous cell carcinoma, or skin
basal cell carcinoma);
5. With hypertension and the blood pressure cannot be reduced to the normal range
through antihypertensive drug treatment (systolic blood pressure greater than or
equal to 140 mmHg or diastolic blood pressure greater than or equal to 90 mmHg).
6. With grade II or higher myocardial ischemia or myocardial infarction, poorly
controlled arrhythmia (including QTc interval more than or equal to 450 ms for men,
more than or equal to 470 ms for female);
7. according to the criteria of NYHA, cardiac insufficiency of grade III and IV or left
ventricular ejection fraction (LVEF) less than 50% revealed by echocardiography;
8. abnormal coagulation function (INR > 1.5 or prothrombin time (PT) > ULN+4 seconds or
APTT >1.5 times the ULN), with bleeding tendency or under thrombolysis or
anticoagulation therapy;
9. within 3 months before enrollment, clinically significant bleeding symptoms occur, or
having obvious bleeding tendency, such as gastrointestinal bleeding, bleeding gastric
ulcer, occult blood + + and above in baseline period, or suffering from vasculitis,
et al;
10. within 4 months before enrollment receiving major surgery or getting severe traumatic
injury, fracture or ulcer;
11. having factors that affect the absorption of the oral drugs obviously, such as the
inability to swallow, chronic diarrhea and intestinal obstruction, et al;
12. urine routine test with urinary protein more than ++, or 24 hour urinary protein more
than 1.0 g;
13. with symptomatic serous cavity effusion, which needs to be surgically managed
(including pleural effusion, ascites, pericardial effusion);
14. with other possible conditions that can affect the clinical research or evaluation of
the results judged by the researchers.

Additional Information

With the comprehensive treatment of breast cancer wildly used in the clinical practice, the
life quality of the patients with breast cancer has been improved greatly, and the survival
of the patients has been extended as well. However, the treatment of the patients with
recurrent and metastatic breast cancer remains a major problem. There is still a lack of
effective targeted therapy for Her-2 negative breast cancer.
Based on the present researches on the anti-angiogenesis drugs in advanced breast cancer,
the investigators believe that it is necessary to further explore the efficacy and safety of
apatinib in advanced breast cancer. The aim of this research is to evaluate the
progression-free survival (PFS) of the patients with HER-2 negative advanced breast cancer
with chest wall metastasis in the treatment of apatinib.

Trial information was received from ClinicalTrials.gov and was last updated in August 2016.

Related Tags

A protein on the surface of some cells that binds to biologic substance called stem cell factor (SCF). SCF causes certain types of blood cells to grow. The stem cell factor receptor is found at high levels or in a changed form on some types of cancer cell

A recombinant therapeutic agent which is chemically identical to or similar to endogenous vascular endothelial growth factor (VEGF). Produced by a wide variety of cell types, endogenous VEGF is a homodimeric, glycosylated protein that is a highly specifi